| CTRI Number |
CTRI/2024/12/078224 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Study of Efficacy and Safety of Travoprost 0.004 percent Versus Timolol 0.5 percent Eye Drops in Primary Open-Angle Glaucoma Patients |
|
Scientific Title of Study
|
Comparative Efficacy and Safety of Topical Eye Drops Travoprost 0.004 percent Versus Timolol 0.5 percent in Patients with Primary Open Angle Glaucoma in a Tertiary Care Teaching Hospital A Prospective Open Label Parallel Group Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RITU RUCHI KERKETTA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GMC NAGPUR |
| Address |
Government medical College and hospital, Hanuman nagar, Ajni Road, Medical Chowk, Ajni
Government medical College and hospital, Hanuman nagar, Ajni Road, Medical Chowk, Ajni
Nagpur
MAHARASHTRA
440003
India |
| Phone |
07979062803 |
| Fax |
|
| Email |
ruchienjoylife@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. CHETNA A. SHAMKUWAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MUHS |
| Address |
Department of Pharmacology
Government medical College and hospital, Hanuman nagar, Ajni Road, Medical Chowk, Ajni
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8208941958 |
| Fax |
|
| Email |
chelsycosmos@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RITU RUCHI KERKETTA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
MUHS |
| Address |
DEPARTMENT OF PHARMACOLOGY Government medical College and hospital, Hanuman nagar, Ajni Road, Medical Chowk, Ajni
Nagpur
MAHARASHTRA
440003
India |
| Phone |
07979062803 |
| Fax |
|
| Email |
ruchienjoylife@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical College and hospital, Hanuman nagar, Ajni Road, Medical Chowk, Ajni
Nagpur
MAHARASHTRA
440003
India |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| Type of Sponsor |
Other [Not applicable] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritu Ruchi Kerketta |
Government Medical College and hospital, Nagpur |
Department of Ophthalmology Hanuman nagar, Ajni Road, Medical Chowk, Ajni
Nagpur
MAHARASHTRA
440003
India
Nagpur
MAHARASHTRA |
07979062803
ruchienjoylife@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMC Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Timolol 0.5 percent eye drops |
Group B will receive Timolol 0.5 percent 1 drop per eye twice daily (9 AM
morning and 9 PM evening) and assessed at baseline, 4 weeks, 8 weeks and 12 weeks |
| Intervention |
Travoprost 0.004 percent eye drops
|
Group A will receive Travoprost 0.004 percent 1 drop per eye once daily (9 PM
evening) and assessed at baseline, 4 weeks, 8 weeks and 12 weeks
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged ≥ 40 years of either gender
2. Best corrected visual acuity ≥ 6 / 60
3. Newly diagnosed patients of primary open-angle glaucoma with mean intraocular pressure (IOP) of 24-36 mm Hg in at least one eye
4. Subjects willing to give written informed consent
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| difference of reduction in mean intraocular pressure in patients with Primary Open Angle Glaucoma receiving Travoprost 0.004% and Timolol 0.5 % eye drops from baseline at the end of 12 weeks |
from baseline at the end of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of adverse events reported by patients with Primary Open Angle Glaucoma receiving Travoprost 0.004% and timolol 0.5 % eye drops from baseline at the end of 12 weeks
2.Assessment of medication adherence – comparison of medication adherence to study drug will be done by medication adherence reporting scale (MARS-10)
|
from baseline at the end of 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to compare the efficacy and safety of Travoprost 0.004% and Timolol 0.5% eye drops in patients with Primary Open-Angle Glaucoma (POAG). It is a prospective, open-label, parallel-group study which will be conducted at a tertiary care teaching hospital over 12 weeks. The primary objective is to assess the reduction in intraocular pressure (IOP), while secondary objectives include evaluating safety (adverse drug reactions) and medication adherence using a validated scale. Forty-two patients meeting inclusion criteria will be randomized into two groups. Travoprost is hypothesized to demonstrate superior efficacy, safety, and adherence compared to Timolol, which will be analysed in this study. |